The Mumbai-based pharma major Wockhardt Ltd has received the final approval for its anticonvulsant drug Divalproex sodium extended tablets 250 mg from the US Food and Drug Administration (FDA). The company has also bagged a tentative approval for the 500 mg ER tablets of the product.
GTC Biotherapeutics and Ovation Pharmaceuticals, Inc. announced that the US Food and Drug Administration (FDA) approved ATryn (Antithrombin [Recombinant]) for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. It is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients.
Biosense Webster, Inc., a Johnson & Johnson company, announced that the US Food and Drug Administration (FDA) has granted marketing approval to the Navistar Thermocool Catheter for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. Atrial fibrillation, or AFib, is a highly prevalent heart rhythm disorder and one of the most common causes of stroke.
Taro Pharmaceutical Industries Ltd. announced that the company has received a warning letter on February 5, 2009 from the US Food and Drug Administration (FDA) regarding the inspection of the company's Canadian manufacturing facility in July 2008. This is the first such letter that the company or any of its affiliates has ever received.